TOOTHACHE AND GUM RELIEF- benzocaine, menthol liquid 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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5820375 CVS Toothache & Gum Relief Liquid

Drug Facts

Active ingredients

Benzocaine 20%

Menthol 0.1%

Purpose

Oral pain reliever

Oral pain reliever

Uses

for the temporary relief of pain due to

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
  • for teething
  • in children under 2 years of age

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
  • allergic reaction occurs

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive ingredients alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

TAMPER-EVIDENT: Carton is sealed for your protection.

Retain carton for complete product information.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP-CVS

Made in Canada

CVS Health™

SEVERE PAIN RELIEF

Toothache & Gum Relief Liquid

ORAL PAIN RELIEVER

DOUBLE MEDICATED​

0.5 FL OZ (14.7 mL)

CVS_SeverePain_Liquid_Ctn_F8015375

TOOTHACHE AND GUM RELIEF 
benzocaine, menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-353
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALCOHOL (UNII: 3K9958V90M)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colororange (Red orange) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-353-291 in 1 CARTON02/07/2019
114.7 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/07/2019
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(69842-353)

Revised: 1/2023
Document Id: f32db032-c55a-5e80-e053-2995a90af098
Set id: 814ec7bf-f825-1095-e053-2a91aa0aee59
Version: 3
Effective Time: 20230126
 
CVS Pharmacy